Zometa
Maa: Euroopan unioni
Kieli: englanti
Lähde: EMA (European Medicines Agency)
Pakkausseloste
(PIL)
24-01-2024
Valmisteyhteenveto
(SPC)
24-01-2024
Julkisesta arviointikertomuksesta
(PAR)
24-11-2015
Aktiivinen ainesosa:
zoledronic acid, zoledronic acid monohydrate
Saatavilla:
Phoenix Labs Unlimited Company
ATC-koodi:
M05BA08
INN (Kansainvälinen yleisnimi):
zoledronic acid
Terapeuttinen ryhmä:
Drugs for treatment of bone diseases
Terapeuttinen alue:
Cancer; Fractures, Bone
Käyttöaiheet:
Prevention of skeletal related events (pathological fractures, spinal compression, radiation or surgery to bone, or tumour-induced hypercalcaemia) in patients with advanced malignancies involving bone;treatment of tumour-induced hypercalcaemia (TIH);prevention of skeletal related events (pathological fractures, spinal compression, radiation or surgery to bone, or tumour-induced hypercalcaemia) in patients with advanced malignancies involving bone;treatment of tumour-induced hypercalcaemia (TIH);prevention of skeletal related events (pathological fractures, spinal compression, radiation or surgery to bone, or tumour-induced hypercalcaemia) in adult patients with advanced malignancies involving bone;treatment of adult patients with tumour-induced hypercalcaemia (TIH).
Tuoteyhteenveto:
Revision: 36
Valtuutuksen tilan:
Authorised
Valtuutus päivämäärä:
2001-03-20
Pakkausseloste
83
B. PACKAGE LEAFLET
84
PACKAGE LEAFLET: INFORMATION FOR THE USER
ZOMETA 4 MG POWDER AND SOLVENT FOR SOLUTION FOR INFUSION
zoledronic acid
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE
BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
−
Keep this leaflet. You may need to read it again.
−
If you have any further questions, ask your doctor, pharmacist or
nurse.
–
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Zometa is and what it is used for
2.
What you need to know before you are given Zometa
3.
How Zometa is used
4.
Possible side effects
5.
How to store Zometa
6.
Contents of the pack and other information
1.
WHAT ZOMETA IS AND WHAT IT IS USED FOR
The active substance in Zometa is zoledronic acid, which belongs to a
group of substances called
bisphosphonates. Zoledronic acid works by attaching itself to the bone
and slowing down the rate of
bone change. It is used:
•
TO PREVENT BONE COMPLICATIONS,
e.g. fractures, in adult patients with bone metastases (spread
of cancer from primary site to the bone).
•
TO REDUCE THE AMOUNT OF CALCIUM
in the blood in adult patients where it is too high due to the
presence of a tumour. Tumours can accelerate normal bone change in
such a way that the
release of calcium from bone is increased. This condition is known as
tumour-induced
hypercalcaemia (TIH).
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN ZOMETA
Follow carefully all instructions given to you by your doctor.
Your doctor will carry out blood tests before you start treatment with
Zometa and will check your
response to treatment at regular intervals.
YOU SHOULD NOT BE GIVEN ZOMETA:_ _
−
if you are breast-feeding.
−
if you are allergic to zoledronic acid, another bisphosphonate (the
group of substances to which
Zometa belongs), or any of the other ingredients of this medicine
(listed in section 6).
WARNINGS AND PRECAUTIONS
TALK TO YOUR DOCTOR BEFORE
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Valmisteyhteenveto
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Zometa 4 mg powder and solvent for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One vial contains 4 mg zoledronic acid, corresponding to 4.264 mg
zoledronic acid monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder and solvent for solution for infusion
White to off-white powder and clear, colourless solvent.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
-
Prevention of skeletal related events (pathological fractures, spinal
compression, radiation or
surgery to bone, or tumour-induced hypercalcaemia) in adult patients
with advanced
malignancies involving bone.
-
Treatment of adult patients with tumour-induced hypercalcaemia (TIH).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Zometa must only be prescribed and administered to patients by
healthcare professionals experienced
in the administration of intravenous bisphosphonates. Patients treated
with Zometa should be given the
package leaflet and the patient reminder card.
Posology
_Prevention of skeletal related events in patients with advanced
malignancies involving bone_
_Adults and older people _
The recommended dose in the prevention of skeletal related events in
patients with advanced
malignancies involving bone is 4 mg zoledronic acid every 3 to 4
weeks.
Patients should also be administered an oral calcium supplement of 500
mg and 400 IU vitamin D
daily.
The decision to treat patients with bone metastases for the prevention
of skeletal related events should
consider that the onset of treatment effect is 2-3 months.
_Treatment of TIH _
_Adults and older people _
The recommended dose in hypercalcaemia (albumin-corrected serum
calcium
≥
12.0 mg/dl or
3.0 mmol/l) is a single dose of 4 mg zoledronic acid.
_Renal impairment _
_TIH: _
Zometa treatment in TIH patients who also have severe renal impairment
should be considered only
after evaluating the risks and benefits of treatment. In the clinical
studies, patients with se
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